RELiZORB significantly increased plasma levels of omega-3 fatty acids and patients reported a decrease in the frequency of gastrointestinal symptoms in a Pivotal Clinical Trial
Warren, NJ. – July 31, 2017 – Alcresta Therapeutics, Inc., dedicated to developing products designed to address challenges faced by people living with gastrointestinal disorders and rare diseases, announced publication of data from a pivotal clinical study of their product RELiZORB, a novel in-line digestive enzyme cartridge indicated for use in pediatric patients (ages 5 years and above) and adult patients to hydrolyze fats while receiving enteral nutrition.
The results are published in the Journal of Pediatric Gastroenterology & Nutrition July 2017, Volume 65, Issue 1; Increased Fat Absorption from Enteral Formula Through an In-line Digestive Cartridge in Patients with Cystic Fibrosis.1
Patients with cystic fibrosis (CF) use pancreatic enzyme replacement therapy (PERTs) in conjunction with oral meals to increase the absorption of fat and other nutrients. Patients who lack the ability to break down fats into digestible forms often have to supplement their nutrition with enteral feedings that are administered overnight. These patients often have no appetite when waking up in the morning and often skip breakfast; thus missing out on consumption of critical calories. Since these patients can’t properly absorb fats, they have known fatty acid deficiencies and are the most representative pediatric population with fat malabsorption using enteral nutrition. Omega-3 fatty acids are structural components of cellular membranes found in a variety of human tissues and also biological anti-inflammatory mediators involved in the regulation of various physiological functions.2
Alcresta Therapeutics completed a multicenter, randomized, double-blind, placebo-controlled crossover clinical study in adult and pediatric patients with CF receiving enteral feeding. The purpose was to evaluate the safety, tolerability (evaluated through analysis of gastrointestinal (GI) symptoms and select activities of daily living), and fat absorption with use of RELiZORB as a part of the enteral feeding circuit in patients with CF who have confirmed exocrine pancreatic insufficiency (EPI). Patients ranged from 5 to 45 years of age, with a mean age of 14.5 years and had received enteral nutrition nightly for a mean of 6.6 years. Despite long-term, enteral nutrition treatment, they still had omega-3 fatty acid levels well below those found in healthy humans, and BMI percentiles that were significantly below targets for patients with CF.
The duration of the study was 27 days and 33 patients completed it. Both GI symptoms and non-GI adverse events were captured during the study. A decrease in the frequency of most GI symptoms of malabsorption was observed with digestive cartridge use. RELiZORB use during administration of enteral nutrition resulted in a 2.8-fold increase in DHA and EPA (omega-3 fatty acids) as measured by plasma absorption. After a single administration, levels reached those comparable to the healthy population as reported in the literature.
“The publication of Study 497 is an important milestone as we build evidence in support of RELiZORB in this patient population,” said Daniel Tassé, Chief Executive Officer, Alcresta Therapeutics. “Patients who receive enteral nutrition often struggle to maintain a healthy nutritional status, and often miss out on consumption of critical calories. The results of this study provide us with the first well-controlled, randomized, double-blind study that showed improvements of fat absorption in patients on enteral nutrition within just 24 hours of treatment with RELiZORB.”
“The increase in DHA and EPA plasma levels in the 497 study demonstrates that this strategy can increase absorption of fats and in particular critical healthy omega-3 fatty acids” said Steven Freedman MD PhD, Chief Division of Translational Research at Beth Israel Deaconess Medical Center. "These are potentially important clinical benefits for patients who are put on nighttime enteral feedings but are waking up full, not eating breakfast and not benefitting from the positive caloric value that having a meal offers. This study is evidence of an important option that is now available to help these patients and their physicians meet important nutritional goals.”
The study can be found on the Journal of Pediatric Gastroenterology & Nutrition web site at:
About Alcresta® Therapeutics, Inc.
Alcresta Therapeutics, Inc. is dedicated to developing and commercializing novel enzyme-based products designed to treat gastrointestinal disorders and rare diseases. The company uses its proprietary technology platform to support a broad pipeline of products, with an initial focus on pancreatic insufficiency, which results in malabsorption common in cystic fibrosis, digestive cancers, premature birth and other serious diseases
The Alcresta Therapeutics, Inc. management team has extensive experience in pharmaceutical and nutritional product development. The Corporate office is based in Warren, NJ and is backed by top-tier investors; Athyrium Capital Management, Bessemer Venture Partners, Frazier Healthcare and Third Rock Ventures. More information can be found at www.alcresta.com.
Chief Executive Officer
Alcresta Therapeutics, Inc.
Relizorb is a trademark of Alcresta Therapeutics, Inc. All rights reserved 2017.
1. Freedman S. et al. Increased Fat Absorption from Enteral Formula Through an In-line Digestive Cartridge in Patients With Cystic Fibrosis. J Pediatr Gastroenterol Nutr. 2017. 65(1):97-101
2. Skillman HW and Wischmeyer PE. Nutrition therapy in Critically Ill Infants and Children. J Parenter Enteral Nutr. 2008. 32(5):520-34